NIH Further Restricts Chimp Research
National Institutes of Health Director Francis Collins, MD, PhD, said the agency would put an end to most use of chimpanzees in medical research, tightening restrictions put in place in 2011.
Henceforth, NIH-funded research on chimpanzees can only be performed on a non-breeding group of 50, Collins announced last week, signalling an eventual end to all such research. Other chimps in NIH-sponsored facilities will be moved into federal sanctuaries.
In 2011, the Institute of Medicine had found that chimpanzees were no longer necessary for most research in which they had traditionally been used, and recommended a dramatic reduction in then-current research colonies. Collins had immediately accepted the recommendations in principle, but had not issued a detailed policy until now.
The announcement drew a sharp rebuke from the Texas Biomedical Research Institute in San Antonio, a private facility that maintains one of the largest remaining chimp colonies.
In a statement, the institute said the 50-chimp limit would impede research into hepatitis B and C and Ebola virus as well as diseases that only affect chimps and other great apes.
"The pace of research will be slowed even more, and human and chimpanzee lives will be lost unnecessarily due to delays in bringing new drugs and vaccines to market," the institute charged.
BP Combo Pill Succeeds in Trial
A pill combining nebivolol with valsartan was superior to either drug alone for blood pressure reduction in hypertensive patients in an 8-week phase III trial, its manufacturer said.
With a primary endpoint of change from baseline in sitting trough diastolic pressure, several fixed-dose combinations of nebivolol and valsartan produced reductions of 1.2 to 2.4 mm Hg against nebivolol alone at the same doses, and 3.7 to 4.4 mm Hg versus valsartan alone, according to Forest Laboratories.
Similar differences between the combination and monotherapy were seen for sitting trough systolic pressure, the company said. It characterized the combination as well-tolerated but did not provide comparisons with the individual drugs.
Forest said it planned to apply for U.S. marketing approval early in 2014. It plans to offer five different fixed-dose combinations for the product. A trade name has not been announced.
More Backing for Xolair in Chronic Hives
Earlier phase III results showing that omalizumab (Xolair) provided relief of chronic idiopathic urticaria in some patients were confirmed in a second pivotal trial, its manufacturer said.
After 12 weeks of treatment, about one-third of patients showed complete resolution of symptoms compared with 5% of the placebo group in the GLACIAL trial, according to Novartis. Results were also presented at a European immunology meeting.
Omalizumab binds to circulating IgE, the immunoglobulin species associated most closely with allergy symptoms including urticaria. It is currently approved as an asthma treatment.
Earlier this year, similar results were reported at the American Academy of Allergy, Asthma, and Immunology’s annual meeting for the first phase III trial of omalizabumab for chronic urticaria.
The current standard of care is high-dose antihistamine therapy, which seldom results in full symptom resolution.
Lemtrada Set for European Approval
The multiple sclerosis (MS) drug alemtuzumab (Lemtrada) won the backing of a key European drug advisory committee, paving the way for approval in the EU.
Given in two annual infusion courses, alemtuzumab — formerly sold as Campath for cancer treatment -- produced sharp reductions in relapse frequency in phase III trials involving patients with relapsing forms of MS, though with a small risk of emergence of certain other autoimmune disorders.
In a vote last week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for the drug. The agency usually follows such recommendations.
The FDA is currently considering the drug for U.S. approval with a decision expected this fall.
